The University of Utah Clinical Research SOP (UUSOP-2: FDA Inspections) outlines the procedure for preparation, conduct, and post-inspections actions associated with an FDA inspection.
The OQC and CRSO QA work closely with teams and provide institutional support throughout the inspection. Research teams must notify the Office of Quality Compliance (OQC) and Clinical Research Support Office Quality Assurance (CRSO QA) team when they receive notice of an FDA inspection or are informed of a likely FDA inspection.
Please reach out for assistance.
OQC email: oqc@utah.edu
CRSO email: crsoqa@hsc.utah.edu